D-66637-001 Class II Terminated
FDA drug recall D-66637-001 was initiated by Hospira Inc. on Oct 11, 2013 and is designated Class II. Reason for recall: Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection. The recall status is terminated (terminated Oct 28, 2014). Affected quantity: 70,450 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 13, 2013
- Initiation Date
- Oct 11, 2013
- Termination Date
- Oct 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70,450 vials
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Reason for Recall
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Distribution Pattern
Nationwide
Code Information
Lot #: 27-570-DJ, Exp 03/01/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-66637-001
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026